NCT05011760 [C-11]NPA PET-amphetamine in Cocaine Use Disorders
| NCT ID | NCT05011760 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Rajesh Narendran |
| Condition | Cocaine Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-01-31 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2021-01-31 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study uses \[11C\]NPA positron emission tomography (PET) and a d-amphetamine challenge to image amphetamine induced dopamine release in the striatum in subjects with cocaine use disorders (CUD). Amphetamine-induced dopamine release data from this study will be correlated with \[11C\]NOP-1A VT measured at baseline in the midbrain. \[11C\]NOP-1A PET data will be used from aim 1 (see, Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)
Eligibility Criteria
Inclusion Criteria: 1. Males or females between 18 and 55 years old 2. Fulfil DSM-5 criteria for cocaine use disorder 3. No other current DSM-5 psychiatric or addictive disorders (such as major depressive disorder, bipolar disorders, psychotic disorders, etc.,) 4. No current abuse (six months) of opiates, sedative-hypnotics, amphetamines, and MDMA as well as moderate to severe alcohol or cannabis use (twice a week). Nicotine use will be quantified and controlled between groups using the Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991); 5. Not currently on prescription medical or psychotropic medications 6. No current or past severe medical, endocrine or neurological illnesses including glaucoma, seizure disorders, hypertension, hypercholesterolemia as assessed by a complete medical history and physical 7. Not currently pregnant or breastfeeding 8. No history of significant radioactivity exposure in past year from another research study or occupation that exceeds RDRC guidelines 9. No metallic objects in the body that are contraindicated for MRI 10. No baseline BP ≥ 140/90 and/or HR ≥ 100. 11. No first-degree relative with an MI or stroke prior to middle age 12. No first-degree relative with psychosis or mania. 13. Completed a baseline \[11C\]NOP-1A PET scan in Aim 1 (Study Record: Imaging CRF X NOP interactions in Cocaine Use Disorders)
Contact & Investigator
Rajesh Narendran
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT05011760 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Cocaine Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05011760 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05011760 currently recruiting?
Yes, NCT05011760 is actively recruiting participants. Contact the research team at narendranr@upmc.edu for enrollment information.
Where is the NCT05011760 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT05011760 clinical trial?
NCT05011760 is sponsored by Rajesh Narendran. The principal investigator is Rajesh Narendran at University of Pittsburgh. The trial plans to enroll 30 participants.